Clinical trial participants should have a say in new drug pricing

People who volunteer to participate in clinical trials of new drugs provide a valuable service to pharmaceutical companies and to the rest of us. In return, I think that they should have a say in how much these drugs will cost when they hit the market. Not only would that honor their service, but it would also provide a patient-centered mechanism to lower the price of new drugs.

The high cost of prescription drugs is a huge problem. It was a central topic in last year’s presidential election and continues to remain a pressing issue for legislators, policymakers, and the public. One of the major challenges is that it is often unclear exactly what drugs cost. Currently, we see a kind of shell game taking place between pharmaceutical companies (who set the initial price), insurance companies (who pay the bill and set premiums), and pharmacy benefit managers (who negotiate secret rebates on behalf of the insurance company). Each party is now pointing fingers at the others for concealing the true price of medications and putting profits ahead of patient benefits and the public good.

But one group that has a large stake in the cost of drugs has been largely overlooked in this discussion: those brave individuals who participate in drug trials. Although our system of research oversight and regulation has long emphasized the vulnerability of trial participants, I believe that they are also in a potentially powerful position.

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No new drugs can be developed and brought to market without people agreeing to participate in company-sponsored drug trials. They are essentially donating their bodies, and in some cases their lives, for the benefit of future patients — not to mention for the financial enrichment of drug companies. I propose that every drug company should have to work with its clinical trial participants to set a price limit on the new medication, should it come to market, and to put this limit into a binding contract.

This would transform what has been a one-sided donation on the part of clinical trial participants into a two-way negotiation.

This may sound impossible — maybe even absurd. But stick with me for a moment. The drug research enterprise already includes a formal agreement between companies and the individuals who participate in their clinical trials. This is the informed consent document. Individuals must first be told about the details of the trial — and its risks — before they can enroll in it. If they choose to accept the risks, they sign the form and can become official participants in the trial.

Today, informed consent is presented as a “take it or leave it” option. I propose that potential participants should be empowered to say, “Yes, I will allow you, the sponsoring company, to experiment on my body only if you agree that you will not charge more than X dollars for this drug.”

Naysayers might argue that companies will just exploit patients and negotiate for a high price. Hoping for the best, people with no other options often sign up for clinical trials to get access to experimental therapies. Indeed, people generally don’t participate in drug trials if they already have access to effective and affordable treatment options. If people are desperate to get into trials, it might seem unlikely that they would be willing to hold out and bargain with companies. In cancer trials, for example, many participants are facing near-certain death and likely won’t live to see the drug come to market.

But this vulnerability of trial participants is a reason for my proposal, not against it. It is precisely because these individuals are vulnerable that we should enact policies that empower them. Requiring companies to contract with participants over future drug prices does just that. Instead of bodies to be experimented upon, participants become individuals working to enhance medical knowledge. A pricing contract further ennobles their sacrifices by letting them secure better and more accessible treatment options for future patients.

A pricing contract further ennobles their sacrifices by letting them secure better and more accessible treatment options for future patients.

One potential challenge for this policy is establishing a process to settle on fair value for these drugs. Some methods already exist for doing this. For example, health economists have used so-called choice experiments to determine the dollar values that individuals are willing to pay for particular health outcomes. These methods could be folded into the informed consent process. Once a cohort of potential trial participants has been identified, health economists could work with them and the sponsoring drug company to settle on a pricing scale based on the efficacy of the drug. If the parties can agree on a fair scale, that would go into the final informed consent contract and should be published along with the trial results. If no agreement can be reached, the trial doesn’t go forward.

I fully realize that this idea would be a hard sell for drug companies, since it weakens their economic positions in the short term. Yet I believe it could serve their interests in the long term. Negotiating prices fairly and transparently with trial participants could generate considerable good will between the industry and the public, and it would effectively shield companies from the rising chorus of accusations that they are greedy and exploitative.

Drug companies don’t need to love the idea for it to be implemented. The current system of clinical trial oversight didn’t come about voluntarily. It was imposed by Congress in response to justified public outrage over the abuse of subjects in the Tuskegee syphilis study and other research. Public outrage today over exploitative drug pricing could prompt legislators to broaden the contract between drug companies and trial participants to include price setting.

Companies currently experiment on clinical trial participants without having to make any commitment that their sacrifices will be honored and redeemed by the introduction of more accessible, effective, and affordable medications. Congress could correct that by saying that a trial consent document is not valid without a signed pricing contract between the manufacturer and the participants.

This proposal does, of course, have its own complications and challenges. The negotiation process could be corrupted. Participants might value treatment at a price that society still cannot afford. Drug companies might refuse to develop needed medications if they can’t reap profits as high as they are now. And this change in research policy wouldn’t solve all the problems with drug pricing.

But here’s what it would do. It would empower trial participants to better protect their own and future patients’ interests in the research and health care enterprises. It would create a transparent, patient-centered system for determining the fair price for medications. It would provide drug companies with an opportunity to more respectfully engage their future customers, and repair some of their tarnished public image. And it would do all this in a manner that is not only consistent with the major principles of research ethics — respect for persons, beneficence, and justice — but would amplify their expression.